FDA/CDRH Public Meeting: Oversight of Laboratory Developed Tests (LDTs), Date July 19-20, 2010

NOTICE: MEETING LOCATION HAS BEEN CHANGED. The public meeting has been changed to an alternative site in the Washington, DC metro area to accommodate the significant public response received and requests to attend the public meeting. Details on the new meeting site can be found below.

Since the implementation of the 1976 Medical Device Amendments, the FDA has generally exercised enforcement discretion and not enforced applicable regulations with respect to LDTs, a class of in vitro diagnostics (IVDs) that are manufactured, including being developed and validated, and offered, within a single laboratory. Thus, the FDA has not actively regulated most LDTs.

Initially, laboratories manufactured LDTs that were generally relatively simple, well-understood pathology tests or that diagnosed rare diseases and conditions that were intended to be used by physicians and pathologists within a single institution in which both were actively part of patient care. These tests were ordinarily either well-characterized, low-risk diagnostics or for rare diseases for which adequate validation would not be feasible and the tests were being used to serve the needs of the local patient population. In addition, the components of traditional LDTs were regulated individually by FDA as ASRs or other specific or general reagents, and the tests were (as is still true today) developed and offered in CLIA high-complexity laboratories with extensive experience in using the tests. Today, many LDTs use complex elements that may not be FDA-regulated. Further, these tests are often used to assess high-risk but relatively common diseases and conditions and to inform critical treatment decisions and are often performed in geographically distant commercial laboratories instead of within the patient’s health care setting under the supervision of a patient’s pathologist and treating physician. In addition, even when FDA-approved tests are available for a disease or condition, laboratories often continue to use LDTs that have not been reviewed by the agency. Finally, an increasing number of LDT manufacturers are corporations with publically traded assets rather than hospitals or public health laboratories, which represents a significant shift in the types of tests developed and the business model for developing them.At the same time, diagnostic tests are playing an increasingly important role in clinical decision making and disease management, particularly in the context of personalized medicine. As a result, LDTs that have not been properly validated for their intended use put patients at risk. Risks include risk of missed diagnosis, wrong diagnosis, and failure to receive appropriate treatment. FDA has the statutory authority to assure that devices, including LDTs, are safe and effective for their intended use. Indeed, in April of 2008, the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS), in its report entitled "U.S. System of Oversight of Genetic Testing," recommended that "FDA should address all laboratory tests in a manner that takes advantage of its current experience in evaluating laboratory tests."

The FDA recognizes that while the absence of FDA oversight may make it easier for laboratories to develop and offer tests on a rapid timeline, the absence of a level playing field creates a disincentive to innovation by other manufacturers whose tests are approved or cleared by the agency. As a result, diagnostics critical for patient care may not be developed in a manner that provides a reasonable assurance of safety and effectiveness.In response to these public health risks, the agency has concluded that it should exercise its authority over LDTs. The public would then be assured that the tests used in the provision of healthcare, whether developed by a laboratory or other manufacturer, are safe and effective. However, the FDA recognizes that there are issues unique to the laboratory community that should be taken into consideration when the agency exercises its oversight. The agency also recognizes that the implementation of oversight requires careful consideration so that patients will receive the desired benefits of innovative, yet safe and effective, diagnostic tests, such as tests for rare diseases and conditions. In addition, it is important that the FDA provide a reasonable, predictable, and consistent regulatory policy for ensuring the safety and efficacy of LDTs and provide sufficient time for implementation. This policy should encourage innovation, improve patient outcomes, strengthen patient confidence in the reliability of these products, and may help reduce health care costs.

At this time, the FDA believes that a risk-based application of oversight to LDTs is the appropriate approach to achieve the desired public health benefits and would like to hear from stakeholders, including laboratory professionals, clinicians, patients, and industry, to define the issues that pose the greatest risk to the public health. The public meeting announced in this notice will serve as a forum to discuss issues and stakeholder concerns surrounding LDT oversight.

FDA’s History with Laboratory Developed Tests (LDTs)Courtney Harper, Ph.D., Director, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostic Device Evaluation and Safety, Center for Devices and Radiological Health